HospitalInspections.org

Based on policy review, interview, and documented meeting minutes regarding 1 of 1 employee reviewed (Employee 4), and review of e-mail documentation, it was determined the hospital failed to ensure drug storage was administered in accordance with accepted professional principles and hospital policy. Hospital policies were not developed and implemented to effectively identify and address uncontrolled access of narcotic (controlled) medications from Pyxis units (Automated Dispensing Cabinets) including access by staff who were on a leave of absence and for patients who were discharged.


Findings include:

1. An interview was conducted with I1, the lead RN of the Interventional Radiology Unit (IRU) on 02/17/2012 at 1130. He/she acknowledged that there had been a narcotic diversion problem on the unit in 2011. He/she said one of the nurses on the unit had noticed "suspicious behavior" when Employee 4 was using the Pyxis system. The suspicious behavior prompted I1 to review Pyxis records which identified that Employee 4 was accessing the Pyxis unit and removing narcotic medications for patients that were not assigned to him/her. I1 said Employee 4 was "pulling meds from patients not even in our department." He/she also indicated Employee 4 was removing narcotic medications from the Pyxis units on "off hours" when he/she was not scheduled to work. I1 revealed that after the diversion was identified, a new medication "deviation" report was added to monthly unit meetings held with pharmacy department staff. The report included evaluating the number of times staff removed narcotic medications from the Pyxis units and medication dosages compared with average or "usual" usage. If deviations from the "usual" ranges were found, then an investigation was conducted in order to identify potential diversion problems. I1 said prior to identifying the diversion problem involving Employee 4, he/she was unaware that the pharmacy department was capable of running a "deviation report." He/she further said "we should've been doing it [a deviation report review] before but we weren't." I1 indicated that he/she was unaware of a written policy/procedure for using a Pyxis deviation report to identify medication diversion problems.

2. An interview was conducted with I3, the Operations Manager of Pharmacy Services on 02/17/2012 at 1245. I3 revealed that during "late October or early November" of 2011, a nurse on the IRU reported that Employee 4 was demonstrating suspicious behavior in regards to Pyxis unit use. A "deviation" report was generated in order to investigate the concerns. Information from the report revealed that Employee 4 was removing medications from the Pyxis unit when he/she was not on duty. I3 said past practice for identifying narcotic diversion relied on nursing department staff reports of suspicious behaviors or narcotic discrepancies to the pharmacy department. The pharmacy department would then conduct an investigation. I3 said since the identification of the diversion concerning Employee 4, a medication "discrepancy" report was added to the monthly nurse management meetings for all units. I3 said there were no documented meeting minutes which reflected that medication discrepancy reports were reviewed during the meetings. He/she further said the discrepancy reports from the monthly meetings were not reported to the medication safety committee.

3. A phone interview was conducted with I6, the Regulatory Affairs Coordinator on 02/21/2012 at 1340. He/she said there was no documented investigation of the events involving Employee 4's narcotic diversion. However he/she provided meeting minutes dated 11/17/2011 which included hospital management staff and Employee 4. Review of the meeting minutes reflected "...Findings from June 9, 2011 to November 15, 2011 showed at least 80 occurrences of Fentanyl [narcotic medication] removed. Average for a nurse [is] 8 to 10 times. While on FMLA [Family Medical Leave of Absence] there were 12 instances of removal, all Friday and Saturdays, on off hours. There were 2700 micrograms over 3 weekends. [Employee 4] admitted to diverting. [Employee 4] continued by stating that [he/she] was very surprised that [he/she] could remove meds from [Pyxis] for patients that had been discharged. [He/she] said that when [he/she] was a Manager [he/she] also had unlimited access..." Review of the documentation determined Employee 4 engaged in unauthorized access and removal of narcotic medications for a period of approximately 5 months, including times when he/she was not on duty and when he/she was on FMLA. Additionally, the diversion included accessing and removing narcotic medications from patients who had been discharged from the hospital.

4. The policy titled "Controlled Substances: Handling Process," effective 08/20/2009 was reviewed and reflected "Scheduled II and III Controlled substances will be handled according to standard processes throughout the OHSU Health Care System. These processes are used to assure that the handling of controlled substances meet the following requirements for acquisition, storage, administration...and reconciliation of 'missing' substances...Controlled Substances are secured before, during and after use. Controlled substances removed from secure storage must be fully accounted for in a timely manner and maintained in a controlled environment. Controlled environment is defined as...actively being administered/connected to a patient...stored in a locked, patient-specific storage space...on a person of a registered nurse or LPN [licensed practical nurse] who is transporting and remaining in attendance with a patient..." The "Pyxis: Controlled Substance Count" section of the policy reflected a process for comparing the number of medications contained within each unit drawer with the medication count number.

The policy did not include a process for identifying whether or not staff who were off duty or on an extended leave of absence had accessed the Pyxis units or if staff had accessed medications for discharged patients unless there was a valid reason for the access. This provided opportunities for staff, including Employee 4 to access the Pyxis unit and remove narcotic medications, including medications for discharged patients without being identified. As a result those medications were not maintained in a controlled environment in accordance with the hospital policy.

5. Policies which were updated after the 02/17/2012 onsite survey were reviewed. The policy titled "ADC Automated Dispensing Cabinet [PYXIS] Policies and Procedures," effective 03/01/2012 contained "highlighted updates" which included a manager review of diversion deviation reports on a monthly basis in order to identify potential diversion problems.

Information received during the onsite survey revealed the hospital initiated monthly narcotic "deviation" reviews in order to identify diversion problems. However, it did not initiate the review process until after identifying Employee 4's narcotic diversion problem. The monthly narcotic deviation reviews were not documented and no policy had been developed reflecting the process at the time of the onsite survey in order to ensure the safe and appropriate use of the medications.

Review of the policy titled "ADC Automated Dispensing Cabinet [PYXIS] Policies and Procedures," effective 03/01/2012 "highlighted updates" reflected that discharged patients would be removed from Pyxis access, "...Profile ADC [Pyxis]: Patients are removed 30 minutes post discharge." Updates further reflected specific timeframes for Pyxis access removal of terminated or inactive employees as "...Expired users...Terminated for cause employees will be removed immediately...Terminated employees will be removed weekly [weekly was a highlighted update]...Pyxis Administrator will revoke access of users with no activity >90 days on a monthly basis."

6. An interview was conducted with the Pharmacy Operations Manager, Services Supply Chain and Compliance on 04/12/2012 at approximately 1530. The lack of policy development for identifying staff diversion of controlled medications was reviewed, and the lack of policy development which addressed the control of medications in Pyxis units for discharged patients and by staff who were off duty for an extended leave of absence were reviewed.

A follow-up email from the Pharmacy Operations Manager, Services Supply Chain and Compliance was received on 04/13/2012 at 1300. The email reflected "There was no process to revoke access for FMLA employees until the 90 day non-use parameter was met-we are working to add that to our process..." The lack of an effective process provided opportunities for Employee 4 to access controlled medications when he/she was on FMLA without being identified and therefore the safe and appropriate use of those medications was not maintained.

The e-mail further reflected "...The ADCs automatically/systematically closes a patient profile 30 minutes after the provider discharges the patient in EPIC." According to the meeting minutes dated 11/17/2011 concerning Employee 4 above, Employee 4 was able to access the Pyxis unit and remove controlled [narcotic] medications for patients who were discharged. However, there was no documentation received that a policy had been developed to reflect that discharged patients were to be removed 30 minutes post discharge until the 03/01/2012 policy update above, which was after the onsite survey.